CellulitePhase 4NCT00399854
Evaluation of the Efficacy of Endermologie in Treatment of Cellulite and Body Contouring
A Phase 4 study testing Dhermia® - Industra Mecânica Fina Ltda in people with Cellulite and Body Contouring, run by Hexsel Dermatology Clinic.
Trial summary
The purpose of this study is to perform a clinical assessment of the efficacy of the device DHERMIA® (Industra Mecânica Fina Ltda)in the treatment of cellulite and body contouring Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite, Body Contouring
- What is being tested?
- Dhermia® - Industra Mecânica Fina Ltda
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Jul 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written Informed Consent;
- Subjects agreeing to take part of all procedures of the study (including mechanical massage, photographs), after being fully informed on the objectives and nature of the investigations;
- Female subjects between 25-45 years;
- Subjects presenting with cellulite grades I-III on buttocks and thighs;
- Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the device under investigation;
- Female subjects of childbearing age should present a negative urine pregnancy test and should be using an effective contraceptive method (3 months before the enrollement untill the end of the study);
Show all 10Show fewer
- Body Mass Index (BMI = weight/height2) beetwen 20,0-25,0 and 25,0-29,9;
- Availability of the subject throughout the duration of the study (90 days);
- Availability of the subject in maintaining a stable weight during the study (variation less than 2 kg)
- Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol.
Who cannot join
- Pregnant women or women intending to become pregnant during the study (next 3 months);
- BMI superior 30,0;
- Subjects with diabetes mellitus, cardiac insufficiency, asthma, or bronchitis;
- Subjects participating in other clinical trials;
- Subjects with neoplastic disorders, uncontrolled thyroid disorders or uncontrolled hypertension;
- Subjects with coagulation disorders, using anticoagulants or tendency of bruises;
Show all 18Show fewer
- Subjects with vascular disorders (phlebitis or varicose veins) in the area to be treated;
- Any prior aesthetic surgery affecting the area to be treated (liposuction, Subcision®), 3 months before the study, that may interfere with results;
- Any other prior anti-cellulite treatment or body measures treatment, 30 days prior to the study;
- Subjects with inflammation or active infection in the area to be treated.
- Subjects with a history of adverse effects, which in the investigator's opinion should prevent the patient from participating in the study;
- Patients with cutaneous or vascular alterations, that difficult visualization and documentation of cellulite;
- Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol;
- Subjects who can not come to the visits (one missing visit/ month is allowed);
- Subjects intending to initiate any intensive sport;
- Subjects using analgesics, non-hormonal antiinflammatories, antihistaminics, corticosteroids, or diuretics;
- Subjects tanned, or intending to expose the area of study to sun, artificial UV, or self-tanning during the study;
- Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.
About this study
Official title: Clinical Study for Evaluation of the Efficacy of Mechanical Massage by Endermologie (Dhermia® - Industra Mecânica Fina Ltda) in Treatment of Cellulite and Body Contouring
The purpose of this study is to perform a clinical assessment of the efficacy of the device DHERMIA® (Industra Mecânica Fina Ltda)in the treatment of cellulite and body contouring
Read the detailed description
The present study is a clinical, opened trial and single-center.
The patients were treated by endermologie device. Mechanical massage were performed for 12 weeks in a total of 24 treatment sessions: twice a week.
A set of photographs were took at visit 1 (baseline), visit 2, 3 and 4 with standardized positions and lighting conditions.
- Conditions
- Cellulite, Body Contouring
- Being tested
- Dhermia® - Industra Mecânica Fina Ltda
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dhermia® - Industra Mecânica Fina LtdaDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of effectiveness of treatment based on current classification of cellulite and evaluation of the corporal measures
Secondary outcomes (3)
Assessment of subject's satisfaction
Visual assessments of the treated area before and after treatment
Safety analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startMar 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Hexsel Dermatology Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Doris Hexsel, MD, Study director, Hexsel Dermatology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399854
- Sponsor's protocol ID
- 02CBED0501
- Status last verified
- Nov 2006
- First submitted
- 14 Nov 2006
- Last updated
- 15 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for Evaluation of the Efficacy of Mechanical Massage by Endermologie (Dhermia® - Industra Mecânica Fina Ltda) in Treatment of Cellulite and Body Contouring
- ClinicalTrials.gov ID
- NCT00399854
- Acronym / sponsor ID
- 02CBED0501
- Conditions
- Cellulite, Body Contouring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Hexsel Dermatology ClinicUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Jul 2006
- First posted
- 15 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to perform a clinical assessment of the efficacy of the device DHERMIA® (Industra Mecânica Fina Ltda)in the treatment of cellulite and body contouring
Detailed description
The present study is a clinical, opened trial and single-center.
The patients were treated by endermologie device. Mechanical massage were performed for 12 weeks in a total of 24 treatment sessions: twice a week.
A set of photographs were took at visit 1 (baseline), visit 2, 3 and 4 with standardized positions and lighting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Written Informed Consent;
- Subjects agreeing to take part of all procedures of the study (including mechanical massage, photographs), after being fully informed on the objectives and nature of the investigations;
- Female subjects between 25-45 years;
- Subjects presenting with cellulite grades I-III on buttocks and thighs;
- Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the device under investigation;
Key exclusion criteria (18 listed)
- Pregnant women or women intending to become pregnant during the study (next 3 months);
- BMI superior 30,0;
- Subjects with diabetes mellitus, cardiac insufficiency, asthma, or bronchitis;
- Subjects participating in other clinical trials;
- Subjects with neoplastic disorders, uncontrolled thyroid disorders or uncontrolled hypertension;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dhermia® - Industra Mecânica Fina Ltda | Device | – |
Primary outcome
Assessment of effectiveness of treatment based on current classification of cellulite and evaluation of the corporal measures
3 secondary outcomes
Assessment of subject's satisfaction
Visual assessments of the treated area before and after treatment
Safety analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2006.
Related trials for Cellulite
Not yet recruiting
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Skin Laxity, Localized Adiposity
Not yet recruiting
Pilot Study of Naringenin Beta Carotene Cream for Local Fat Reduction (SCULPT)
Thigh Cellulite
Active, not recruiting
Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite
Cellulite
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris Hexsel, MD study director
Hexsel Dermatology Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dhermia® - Industra Mecânica Fina Ltda in people with Cellulite and Body Contouring, run by Hexsel Dermatology Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of effectiveness of treatment based on current classification of cellulite and evaluation of the corporal measures. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2006.